Highlighting best practices to advance next-generation risk assessment of cosmetic ingredients.

Abstract

Public expectations and regulatory demands have driven a paradigm shift in cosmetic ingredient safety assessment. Next-generation risk assessment (NGRA) and new approach methodologies (NAMs) provide an opportunity to implement alternative procedures which are more ethical and biologically-relevant, have the potential to become more cost-effective and time-efficient, and are at least as protective of human health as traditional, animal-based approaches. However, the sheer number and diversity of the rapidly-evolving NAMs currently available can be confusing and overwhelming to safety assessors. To successfully transition from principles to routine application, NAMs must gain acceptance within safety assessment communities. Harmonizing NAMs and establishing standardized risk assessment workflows are paramount to gaining regulatory acceptance. Consequently, the International Cooperation on Cosmetics Regulation (ICCR) has tasked a team of scientists from regulatory authorities and the cosmetic industry to define best practices which align with the ICCR principles of NGRA for cosmetic ingredients, to help advance the acceptance and use of NAMs in cosmetic safety assessment and, where applicable, regulatory decision-making.